Aortic Arch Related Cerebral Hazard Trial (ARCH) (ARCH)
Prevention of New Vascular Events in Patients With Brain Infarction or Peripheral Embolism and Thoracic Aortic Plaques ≥ 4 mm in Thickness in the Aortic Arch or Descending Aortic Upstream to the Embolized Artery
The ARCH is a controlled trial with a sequential design and with a prospective, randomized, open-label, blinded-endpoint (PROBE) methodology. The objective is to compare the efficacy and tolerance (net benefit) of two antithrombotic strategies in patients with atherothrombosis of the aortic arch and a recent (less than 6 months) cerebral or peripheral embolic event.
Hypothesis:
The association of clopidogrel 75 mg/d plus aspirin 75 mg/d is 25% more effective than an oral anticoagulant (target International Normalized Ratio [INR] 2 to 3) in preventing brain infarction, brain hemorrhage, myocardial infarction, peripheral embolism, and vascular death.
調査の概要
詳細な説明
Patients with Transient Ischemic attack or brain infarction of unknown cause (no ipsilateral internal carotid artery origin stenosis greater than 70%, no ipsilateral severe intracranial stenosis of an artery supplying the infarcted area, no definite cardiac source of embolism) in the preceding 6 months and atherosclerotic plaques.
≥ 4 mm in the aortic arch, or patients with a peripheral event (e.g. renal infarct) in the preceding 6 months and plaque ≥ 4 mm in the thoracic aorta above the origin of the embolized artery.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
Patients of both sexes aged ≥ 18 years with the following 4 inclusion criteria:
One of the 3 following ischemic events in the preceding 6 months:
- Transient ischemic attack (TIA)
Non-disabling brain infarcts:
- Inclusion within 6 months after onset
- Duration of symptoms and signs greater than 24 hours
- Neurological signs at the time of randomization with a Rankin Scale grade 3 or less
- With normal computed tomography (CT) scan or CT scan showing a brain infarct (even hemorrhagic infarct)
- Peripheral embolism
- Atherosclerotic plaque in the thoracic aorta is defined as wall thickness ≥ 4 mm where the protruding material is the largest, measured at transesophageal echocardiography with multiplane transducer or a plaque less than 4 mm but with mobile component.
- Informed consent signed
- Life expectancy > 3 years
Exclusion Criteria:
Other causes of embolism:
- Cardiac: endocarditis, atrial fibrillation, intra-cardiac thrombus, valvular prosthesis, rheumatic valvulopathy, left ventricular aneurysm, or ejection fraction less than 25%
- Atherosclerotic stenosis ipsilateral to the embolic territory: internal carotid artery stenosis greater than 70%, or severe (judgment of the investigator) intracranial stenosis, or scheduled carotid endarterectomy (in that case inclusion is possible 30 days after the procedure)
- Uncommon causes: dissection, vasculitis, procoagulant state, or sickle cell disease
Other exclusion criteria:
- Intercurrent illness with life expectancy less than 36 months
- Pregnancy and non-menopausal women
- Unwillingness to participate
- Poor medication compliance expected
- Toxicomania
- Absolute indication for anticoagulant therapy (e.g. atrial fibrillation, intracardiac thrombus, prosthetic valve)
- Scheduled for carotid endarterectomy (randomization is possible 30 days after endarterectomy)
- CT scan with an intracranial lesion other than brain infarction (space occupying mass, intracranial hemorrhage)
- Transesophageal echocardiography (TEE) with plaque ≥ 4 mm in thickness distal to the supposed embolized artery (judgement of the investigator).
- Contraindication to clopidogrel, aspirin, and oral anticoagulants
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Clopidogrel-aspirin
|
Clopidogrel-aspirin
|
|
アクティブコンパレータ：Warfarin
|
ワルファリン
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
New vascular events assessed every 4 months including stroke, myocardial infarction (MI), peripheral events, and vascular death
時間枠：every 4 months
|
New vascular events assessed every 4 months including stroke, myocardial infarction (MI), peripheral events, and vascular death
|
every 4 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recurrent brain infarction
時間枠：during the trial
|
Recurrent brain infarction
|
during the trial
|
|
brain infarction and transient ischemic attack (TIA)
時間枠：during the studing
|
brain infarction and transient ischemic attack (TIA)
|
during the studing
|
|
new vascular events and revascularization procedure
時間枠：during the trial
|
new vascular events and revascularization procedure
|
during the trial
|
|
vascular death
時間枠：during the trial
|
vascular death
|
during the trial
|
|
death from all causes
時間枠：during the trial
|
death from all causes
|
during the trial
|
|
combination of primary end-point and TIA
時間枠：during the trial
|
combination of primary end-point and TIA
|
during the trial
|
|
revascularization procedures
時間枠：during the trial
|
revascularization procedures
|
during the trial
|
|
urgent rehospitalization for ischemic
時間枠：during the trial
|
urgent rehospitalization for ischemic
|
during the trial
|
協力者と研究者
捜査官
- 主任研究者：Pierre Amarenco, Pr, MD, PhD、Assistance Publique - Hôpitaux de Paris
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
- 虚血
- 病理学的プロセス
- 壊死
- 心血管疾患
- 血管疾患
- 脳血管障害
- 脳疾患
- 中枢神経系疾患
- 神経系疾患
- 塞栓症と血栓症
- 脳虚血
- 脳卒中
- 梗塞
- 塞栓症
- 虚血性発作、一過性
- 脳梗塞
- 薬の生理作用
- 神経伝達物質のエージェント
- 薬理作用の分子機構
- 末梢神経系エージェント
- 酵素阻害剤
- 鎮痛剤
- 感覚系エージェント
- 抗炎症剤、非ステロイド
- 鎮痛剤、非麻薬性
- 抗炎症剤
- 抗リウマチ剤
- 線維素溶解剤
- フィブリン調節剤
- 血小板凝集阻害剤
- シクロオキシゲナーゼ阻害剤
- 解熱剤
- プリン作動性 P2Y 受容体拮抗薬
- プリン作動性 P2 受容体拮抗薬
- プリン作動性拮抗薬
- プリン作動薬
- 抗凝固剤
- アスピリン
- クロピドグレル
- ワルファリン
その他の研究ID番号
- P991205
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